US court orders wider access for morning-after pill (Update 2)

April 5, 2013
by Kerry Sheridan

After a decade-long battle over access to emergency contraception, a federal judge ordered US regulators Friday to make the morning-after pill available over the counter without age limits.

US District Court Judge Edward Korman ruled that a 2011 decision by the chief of US Health and Human Services to require teens under 17 to obtain a prescription was "politically motivated" and "scientifically unjustified."

The ruling orders the Food and Drug Administration to make levonorgestrel-based emergency contraception available over the counter to people under 17 without a doctor's prescription.

Emergency contraceptives contain the same active ingredients as birth control pills but at higher doses, and can prevent pregnancy if taken within 72 hours of unprotected intercourse.

Experts say emergency contraception is most effective during the first 24 hours.

But US pharmacies have required a prescription for those younger than 17. Those above the age limit must present government-issued identification in order to purchase the drug, and it has only been available at pharmacies.

The Center for Reproductive Rights, which brought the latest lawsuit, hailed the ruling as a "landmark decision" and a "victory" for women.

"Today, science has finally prevailed over politics," said Nancy Northup, the group's president.

"No longer will any woman rush into an all-night drugstore only to find the pharmacy gates closed and emergency contraception, which is most effective when taken immediately, just out of her reach."

It was unclear whether the US government would appeal. An FDA spokeswoman told AFP the agency would have no comment on the ruling since it was "an ongoing legal matter."

The battle over access to the morning-after pill, which was approved for prescription use in 1999, has been raging since 2001, with advocates saying there should be wider access and critics warning of health and social dangers.

In December 2011, the Food and Drug Administration was poised to allow over-the-counter access to a morning-after pill called Plan B One-Step, made by Pennsylvania-based Teva Pharmaceuticals.

But this was swiftly blocked by another government agency, Health and Human Services.

HHS Secretary Kathleen Sebelius said there was not enough data on its use by under-17s and cited "significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age."

President Barack Obama supported Sebelius, saying at the time that the government was not confident it should be as available to 10- or 11-year-olds as bubble gum or batteries, and it could have adverse effects if not used properly.

However, Korman's 59-page ruling described US regulators' moves to restrict access as "arbitrary, capricious and unreasonable."

Since fewer than three percent of girls under 13 are sexually active in the United States, "the potential population about whom the secretary is concerned is infinitesimal," he wrote.

His ruling orders the FDA to make Plan B and its generic equivalents available without a prescription and without age restrictions within 30 days.

A single dose of emergency contraception currently costs about $50, and generics cost about $40, women's rights advocates said.

A leading conservative opponent of the morning-after pill expressed "serious concerns" about the ruling.

"There is a real danger that Plan B may be given to young girls, under coercion or without their consent," said Anna Higgins, director of the Center for Human Dignity at the Family Research Council.

"The involvement of parents and medical professionals act as a safeguard for these young girls. However, today's ruling removes these commonsense protections," she said.

But Angela Diaz, director of the Mount Sinai Adolescent Health Center in New York, said she approved of the ruling.

"Research shows that 60 percent of young people are sexually active by 12th grade (age 17-18), and the more tools we have to help them be responsible, the better," she said.

Women's health advocates said Tuesday they will sue the US government for allegedly violating the constitutional rights of young teens by denying them over-the-counter access to emergency contraception.

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